Title

Write an SOP for Recording, Reporting and Archiving of Results

Why

The laboratory is responsible for ensuring that the requester receives the results of laboratory testing correctly, completely and timely.


Recording and reporting of results needs to be done meticulously; if the recording/reporting system of the laboratory is of inadequate quality this can affect the correct transmission of results to the requester. No matter how quality assured the examination is done, with a recording and reporting system that is not standardized and quality controlled, the results are still not quality assured.

What

Write an SOP for Recording, Reporting and Archiving of Results. This SOP must cover the following procedures:

  • Recording of results
    Ensuring correct recording of all the data needed in all the registers, forms and reports necessary.
  • Reviewing and authorizing results for release
    Including checking of correct transcription of results between registers, reports and work forms, and checking completeness of final report by authorized personnel (see activity earlier in phase 2).
  • Normal procedure for reporting of results
    Results must always be reported in a final, authorized official report to the requester, not the patient, by authorized staff members. The results, reference intervals (also made in phase 2) and descriptions must be reported using accepted vocabulary/syntaxes and nomenclature.
  • Immediate notification of the requester of results of urgent samples (also made in phase 2)
  • Immediate notification of the requester in case results fall in critical intervals (this procedure was developed earlier in phase 2). Include the Immediate Notification Form developed earlier in phase 2 as appendix to the SOP.
    This procedure must ensure that if no contact was made with the requester, the laboratory keeps trying to get into contact until contact is made.
  • Reporting via telephone or other electronic means
    Paying attention to proper verification that the correct clinician is called and that the clinician records the correct results for the correct patient.
  • Reporting of results of samples of inadequate quality but that were still tested
    Notifying the clinician of this and explaining that the results should be interpreted with caution as they are less reliable.
  • Alteration of reports
    When it is detected, after reporting of the result, that an examination might have been flawed (for example due to the use a bad quality reagent) the requester needs to be notified of the fact that the result is less reliable or may even be incorrect, so that he/she can undertake action with regard to correct diagnosis and treatment of the patient. The changes to the original report need to be clearly visible and need to be supplied with a date, time and name of the person who made the changes. In electronic reporting systems a track and trace function is needed, which records all modifications.
  • Archiving of results
    Copies of official Result Reports are stored by the laboratory for a specific period of time. When reports are altered, the original report is also archived, together with the revised reports. When results were immediately notified to the requester, the completed Immediate Notification Form must be added to the official Result Report to enable later verification if needed.

How & who

Quality Officer in cooperation with the staff involved in reporting of results:

  1. Make an outline of the SOP in cooperation with the staff that is routinely involved in reporting of results.
  2. Write the SOP following the protocol for writing a Procedure SOP in the Master SOP and use the template for a Procedure SOP attached to the Master SOP.
  3. Review and authorize the SOP according to the procedures in the SOP for Document Control.
  4. When the SOP is ready determine at which locations copies of the SOP must be available and indicate this on the SOP (to facilitate efficient and correct replacement of all copies when a new version of the SOP is printed).
  5. Include the SOP in the Read and Understand List and indicate which staff members have to read the SOP (those who are in any way involved in one of the procedures described in the SOP).
  6. Present the SOP in a weekly staff meeting; explain the contents and who must read the SOP.

Back to Roadmap Activity Overview
This activity belongs to the QSE Information Management
ISO15189:2012: 5.8.1 5.9.1 5.9.3
ISO15190:2003: